Teams at Parexel

The Regulatory Affairs Consultant guides clinical studies through regulatory requirements, advising teams on compliance and strategies for efficient trial execution. They engage with health authorities, manage communication, and ensure quality documentation.

Lead and oversee FSP clinical operations and programs, manage line staff and client accounts, ensure on-time/high-quality deliverables, resource projects, manage KPIs, billing and staffing forecasts, resolve escalations and CAPAs, collaborate cross-functionally, support business development and regional client relationships, and drive process improvements and team development.

Design and code R and SQL programs to clean, validate, and analyze real-world data (Optum, Flatiron). Implement RWE protocols using epidemiological and advanced statistical methods, document analyses for reproducibility, create dashboards/reports, review programming plans, and collaborate with study teams to meet timelines and reporting requirements.